Hundreds of couples are filing a lawsuit after they failed to achieve pregnancy while using the defective infertility treatment drug Bravelle. Manufactured by Ferring Pharmaceuticals, several batches of this hormone-based therapy have been recalled from the market in 2015 since they were ineffective. However, according to the recent storm of litigations filed in court, victims were not aware that they kept being injected with doses of the drug that probably never worked in the first place, and have never been fully refunded of all the expenses they sustained.
Bravelle (urofollitropin) is an In Vitro Fertilization (IVF) therapy used to treat infertility. It works by stimulating a woman’s ovaries into producing new eggs (follicles) which are then fully developed before they met a sperm cell inside the fallopian tube. Once the follicle is fertilized, pregnancy may occur. Urofollitropin is a purified hormone whose activity mimics the one of the luteinizing (LH) and follicle-stimulating (FSH) ones. It is injected subcutaneously in different doses to assist the ovulation process depending on the individual needs.
Bravelle may cause ovarian hyperstimulation syndrome (OHSS) since it induces the ovulation in infertile women. Common side effects include hypotension, vascular disorders, weight gain and electrolyte imbalances. Because of that, the patient needs to be monitored through the entire IVF treatment, forcing many couples to sustain significant expenses in order to travel to distant clinics. Other less common adverse reactions of this medication have been reported, such as skin rash, pelvic pain and temporary alopecia. There is also an unconfirmed risk of endometrial cancer associated with treatment with this hormone.
The Bravelle class action lawsuit
When in September 2015, the drugmaker found that the effectiveness of several batches of Bravelle was compromised, it voluntarily recalled them and offered a reimbursement to the patients who used them. However, in later times many more lots of urofollitropin were also recalled, leaving many families full of doubts on whether the drugs they were injected with was an effective one or not. Since a full IVF treatment may require several cycles, if the medication is defective the expenses may mount up to much more than just the few thousands of dollars offered by Ferring as compensation. Also, the pharmaceutical company’s website never warned about the chance of not being able to achieve pregnancy due to a possible lack of effectiveness of many Bravelle lots. On 2016, a class-action lawsuit has been filed in a British Columbia Court by Joep and Amanda Olthuis.
The Canadian plaintiffs argue that they have never properly warned about the drug’s alleged lack of efficacy, and that they would have chosen a different alternative if they had this choice. The Swiss manufactured only provided them with a $2,500 refund, although the couple had to spend more than $14,000 to cover all the out-of-pocket expenses of the IVF treatment, including weekly transfers to the Genesis Fertility Centre in Vancouver. Couples that missed their opportunity to have a child often experienced serious emotional damage for which they want to hold the pharmaceutical company responsible.
A brief overview on infertility
If a couple fails to achieve pregnancy within one full year of regular unprotected intercourses, then that couple is defined as infertile. However, in up to 95 percent of cases, after another year a baby is conceived without treatment. The small remaining percentage of men and women that are still unsuccessful may still try to improve their chances of conceiving by just following a different diet plan, change their lifestyle habits or stop smoking and drinking. Infertility is a condition that affects both male and female individuals almost equally, although the percentages are slightly skewed in favor of men, since a woman who cannot carry a pregnancy to full term is still computed as an infertile one. If dietary supplementation, sport, and psychological support such as couples therapy are insufficient to allow a couple to reach their objective, other treatments available include surgical and pharmacological alternatives. An in vivo fertilization (IVF) therapy consists of collecting a mature egg from a woman’s ovary, and then manually fertilizing it in a lab setting. IVF is a long and expensive procedure, and may require several cycles to be effective.
Article written by Dr. Claudio Butticè, Pharm.D.
REFERENCES
- CTV News, B.C. couple launches class-action lawsuit over ineffective fertility drug. February 16, 2016. CTVNews.ca
- Centers for Disease Control and Prevention (CDC). Infertility – Reproductive Health. www.cdc.gov (Accessed July 2016)
- Ferring Pharmaceuticals. Bravelle Patient Reimbursement Program Information. com (Accessed September 2016)
- Butticè, February 23, 2016. Coping with infertility – The hardships of conceiving a baby. Meds News
- van Wely, C, et al. Urofollitropin and ovulation induction., in Treat Endocrinol, vol. 4, n. 3, 2005, pp. 155-65, PMID 15898821
- S. Food and Drug Administration (FDA). Bravelle Full Prescribing Information. www.fda.gov (Accessed October 2016)